Concerta XL (methylphenidate)

Main use

Active ingredient

Manufacturer

ADHD

Methylphenidate hydrochloride

Janssen-Cilag

How does it work?

Concerta XL tablets contain the active ingredient
methylphenidate hydrochloride, which is a type of medicine called a stimulant.
It is used to treat attention deficit hyperactivity disorder (ADHD) in
children. (NB. Methylphenidate tablets are also available without a brand name,
ie as the
generic medicine.)

Stimulants are related to amphetamines, which might make them
seem an odd choice for treating hyperactive children, because stimulants
increase activity in the brain and normally make people more alert and active.
However, stimulants at the doses used for ADHD have the opposite effect.

Methylphenidate works by affecting some of the natural
chemicals that are found in the brain. In particular, it increases the activity
of chemicals called dopamine and noradrenaline in areas of the brain that play
a part in controlling attention and behaviour. These areas seem to be
underactive in children with ADHD. It is thought increasing the activity of
these chemicals improves the function of these underactive parts of the brain.
We still dont fully understand how stimulants work in children with
ADHD, and they dont work for everyone. But they can be very useful at
helping some children to learn to control their behaviour.

Concerta XL tablets are a prolonged-release formulation of
methylphenidate that only needs to be taken once a day. The tablets are designed to release a small amount of the medicine immediately, as the outer layer of the tablet dissolves. The rest of the medicine is
then released gradually from a special membrane inside the tablet over the rest of the day, giving effects that last for up to 12 hours.

Concerta XL tablets
must be swallowed whole. They must not be chewed, broken or crushed, as
this would stop the prolonged-release action from working and cause all the
medicine to be released at once.

What is it used for?

Methylphenidate is not used for all children with ADHD. It is
used as part of a comprehensive treatment programme for ADHD that includes
psychotherapy and behavioural management techniques, and is only used in
children in whom these treatments have proved to be insufficient on their own.
It should only be used under the supervision of a specialist in childhood
behavioural disorders, and only after the severity of the child's symptoms has
been thoroughly assessed.

The medicine can be continued into adolescence and adulthood if ADHD symptoms continue and you are still benefiting from the medicine.

How do I take it?

The usual starting dose of Concerta XL is one 18mg tablet daily. Your doctor may increase this to either one 27mg or one 36mg tablet daily, depending on the response to the medicine. The maximum daily dosage of Concerta XL is 54mg.

Concerta XL tablets should be taken once a day in the morning. They can be taken either with or without food.

The tablets should be swallowed whole with a drink. They must not be chewed,
broken or crushed.

If you forget to take your tablet in the morning you should not take it later in the day, because this may cause problems with sleeping during the night. Instead, leave out the forgotten dose and just take your next dose as usual the following morning. Dont take a double dose to make up for a missed dose.

If symptoms have not improved after one month of taking this medicine your doctor may decide to stop treatment. Where symptoms have improved, the medicine should be stopped from time to time, usually at least once a year, so that the condition can be assessed and to check if the medicine is still needed. However, in both cases, this medicine must not be stopped suddenly without your doctor's advice. When stopping treatment, the medicine should be withdrawn gradually, following the instructions given by your doctor.

Warning!

Concerta XL tablets don't dissolve completely after the
medicine has been released in the intestines and the shell of the tablets may
sometimes be visible in your stools. This is normal and nothing to worry
about.

This medicine may cause dizziness, drowsiness and visual disturbances. If affected, you should avoid activities that could be potentially hazardous, such as climbing trees, riding bikes or horses, driving or operating machinery.

You should not drink alcohol while taking this medicine.

Children should have their height, weight and appetite checked before starting this medicine and then regularly every six months as long as treatment is continued. If your child is not growing or gaining weight satisfactorily, your doctor may suggest breaks from the medicine to allow growth to catch up.

Your child's blood pressure and heart rate (pulse) should also be checked before starting treatment and then at least every six months and after any dose changes, particularly if your child has existing high blood pressure.

If your child experiences any heart palpitations, chest pain when exercising, or shortness of breath, or if they faint for no apparant reason, you should let your doctor know straight away.

You should also tell your doctor if any other symptoms or side
effects are experienced during treatment. In particular, children and adolescents taking this
medicine should be encouraged to report any new or worsening distressing
thoughts or feelings, anxiety, agitation, irritability, depression, mood changes, or other unusual
change in behaviour that they may experience after starting this medicine. If
you are worried about your child at any point it is important to talk to your
doctor immediately.

Use with caution in

People with marked anxiety, agitation or tension.

People with a personal or family history of involuntary muscle spasms
(twitches or tics).

People with a personal or family history of Tourette's syndrome
(characterised by involuntary repetition of speech, in particular obscene or
vulgar words).

As Concerta XL tablets must be swallowed whole, this form of methylphenidate is not appropriate for people who have difficulty swallowing or who have any unusual narrowing in the stomach or intestines.

Concerta XL tablets contain lactose and are not suitable for
people with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one or
any of its ingredients. Please inform your doctor or pharmacist if you have
previously experienced such an
allergy.

If you feel you have
experienced an allergic reaction, stop using this medicine and inform your
doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or
breastfeeding. However, other medicines may be safely used in pregnancy or
breastfeeding providing the benefits to the mother outweigh the risks to the
unborn baby. Always inform your doctor if you are pregnant or planning a
pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not
been established. It is not recommended for use in pregnancy unless considered
essential by your doctor. Seek further medical advice from your doctor.

If you are having sex it is important to use an effective method of contraception to avoid getting pregnant while you are taking this medicine. If think you could be pregnant or want to plan a pregnancy it is important to talk to your doctor straight away.

This
medicine may pass into breast milk and could have harmful effects on a nursing infant. It should not be taken by mothers who are breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual
people in different ways. The following are some of the side effects that are
known to be associated with this medicine. Just because a side effect is stated
here does not mean that all people using this medicine will experience that
or any side effect.

See the warning section above for more information about some of these side effects.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Very rare (affect less than 1 in 10,000 people)

Cold hands and feet.

Disturbances in the normal numbers of blood cells in the blood. Your doctor may want to do blood tests from time to time to make sure there are no problems with your blood cells.

Liver problems. Symptoms that could indicate liver problems
include unexplained itching, nausea and vomiting, right-sided abdominal pain,
loss of appetite or flu-like symptoms; yellowing of the skin or eyes
(jaundice); or unusually dark urine. Tell your doctor if you experience any of these symptoms while taking this medicine.

Inflammation of the arteries in the brain (cerebral arteritis).

Heart attack.

Convulsions (fits).

The side effects listed above may not include all of the side
effects reported by the medicine's
manufacturer.

For more
information about any other possible risks associated with this medicine,
please read the information provided with the medicine or consult your doctor
or pharmacist.

How can this medicine affect other medicines?

You should tell your doctor what medicines your child is already
taking before they start treatment with this medicine. This includes medicines
bought without a prescription and herbal medicines. Likewise, once treatment
has started you should always check with your doctor or pharmacist before
using any new medicines, to make sure the
combination is safe.

If this medicine is taken within 14 days of taking a monoamine
oxidase inhibitor antidepressant (MAOI, eg tranylcypramine, phenelzine,
isocarboxazid, moclobemide) there may be a risk of a dangerous rise in blood pressure
(hypertensive crisis). For this reason methylphenidate should not be taken by
people who have taken an MAOI in the previous 14 days.

Check with your pharmacist before giving cough and cold remedies
to children taking methylphenidate, as these types of medicines sometimes
contain ingredients that may affect blood pressure, and could be unsuitable to
use in combination with methylphenidate.

Methylphenidate may increase the blood levels of the following
medicines:

The materials in this web site are in no way intended to replace the professional medical care, advice, diagnosis or treatment of a doctor. The web site does not have answers to all problems. Answers to specific problems may not apply to everyone. If you notice medical symptoms or feel ill, you should consult your doctor - for further information see our Terms and conditions.